Amoxicillin and Clavulanate Potassium

Product NDC
66685-1011
Requested package NDC
66685-1011-2
11-digit product format
666851011
Labeler code
66685
Product ID
66685-1011_547fbb63-1dc2-4023-bfa9-b8061af1f33c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amoxicillin and clavulanate potassium
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA065098
Marketing category
ANDA
Marketing start
2004-08-13
Marketing end
0000-00-00
Substance
AMOXICILLIN; CLAVULANATE POTASSIUM
Active strength
200 mg/5mL; mg/5mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage66685-101166685-1011-2DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16
A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A065098-001AB
A065098-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1684e616aacf4f…
2026-09-14 22:38:342026-08A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1684e616aacf4f…
2026-08-18 06:07:402026-07A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16caaa826d4ba7…
2026-08-18 06:07:402026-07A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065098-001AMOXICILLIN AND CLAVULANATE POTASSIUM200MG/5ML;EQ 28.5MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065098-002AMOXICILLIN AND CLAVULANATE POTASSIUM400MG/5ML;EQ 57MG BASE/5MLFOR SUSPENSION / ORALAB2002-12-1674a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A065098-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A065098-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A065098-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A065098-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065098-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065098-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065098-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065098-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065098-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065098-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065098-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065098-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065098-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065098-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065098-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065098-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065098-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065098-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065098-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065098-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065098-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065098-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065098-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065098-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065098-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065098-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065098-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065098-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065098-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065098-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065098-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065098-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065098-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065098-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065098-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065098-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065098-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065098-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065098-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065098-002AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
502415e5-4ac7-4266-a01a-ef44aa3c028dProduct name720250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0fProduct name320250620
2ebbc361-d28f-48a9-a286-c1ae09cdaf5cProduct name320230314
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
cf3f1c02-1f32-2322-3314-b70ebbf5610eProduct name120140508
ebb3e917-326a-9e18-0354-a19c9f63a2f3Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66685-1011-0ML - Milliliter66685-1011439eb30b-494f-4012-bd15-8949e9786f7312013-02-13
66685-1011-1ML - Milliliter66685-1011611b106f-920a-4af8-8994-d3a44f057a5a12013-02-13
66685-1011-2ML - Milliliter66685-10110e61e352-a90b-4eaf-bcd5-86572c44c08712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
CARAMELINACTIVE INGREDIENTT9D99G2B1RAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
ORANGEINACTIVE INGREDIENT5EVU04N5QUAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
RASPBERRYINACTIVE INGREDIENT4N14V5R27WAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
TALCINACTIVE INGREDIENT7SEV7J4R1UAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]8
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
AMOXICILLINACTIVE INGREDIENT804826J2HUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
CLAVULANATE POTASSIUMACTIVE INGREDIENTQ42OMW3AT8AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
AMOXICILLIN ANHYDROUSACTIVE MOIETY9EM05410Q9AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
CLAVULANIC ACIDACTIVE MOIETY23521W1S24AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
RASPBERRYINACTIVE INGREDIENT4N14V5R27WAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [PROFICIENT RX LP]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66685-1011AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [SANDOZ INC]13Legacy NDC20241006_bbe8c7ec-9dfe-4fea-bbb7-e74671e6226f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions029a49f2-2132-4160-a0d6-2d108a456a222023-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065098
application number: ANDA065098

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSN9b22f89a-be3d-4d10-8fdd-f92e265c83fb7
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCD9b22f89a-be3d-4d10-8fdd-f92e265c83fb7
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSY9b22f89a-be3d-4d10-8fdd-f92e265c83fb7
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSY9b22f89a-be3d-4d10-8fdd-f92e265c83fb7
617423amoxicillin 200 MG / clavulanic acid 28.5 MG in 5 mL Oral SuspensionPSN2970fe7e-9e1f-47aa-85ad-663ee15c7e061
617423amoxicillin 40 MG/ML / clavulanate 5.7 MG/ML Oral SuspensionSCD2970fe7e-9e1f-47aa-85ad-663ee15c7e061
617423amoxicillin (as amoxicillin trihydrate) 200 MG / clavulanic acid (as clavulanate potassium) 28.5 MG per 5 ML Oral SuspensionSY2970fe7e-9e1f-47aa-85ad-663ee15c7e061
617423amoxicillin 200 MG / clavulanic acid 28.5 MG per 5 ML Oral SuspensionSY2970fe7e-9e1f-47aa-85ad-663ee15c7e061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66685-1011-266685101102100 mL in 1 BOTTLE (66685-1011-2) 100 ml2004-08-130000-00-00NoNoCurrent